Pain, Acute Post-OperativeNCT07655908
Catheter Redosing of Autonomic Neural Blockade After Sleeve Gastrectomy
A study testing Bupivacaine 0.5% and Dexamethasone via Temporary Catheter in people with Pain, Acute Post-Operative and Nausea and Vomiting, Postoperative, run by Universidad Simón Bolívar.
Trial summary
Postoperative visceral pain and autonomic symptoms after laparoscopic sleeve gastrectomy may reappear earlier in selected high-risk patients despite standard intraoperative autonomic neural blockade (ANB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute Post-Operative, Nausea and Vomiting, Postoperative
- What is being tested?
- Bupivacaine 0.5% and Dexamethasone via Temporary Catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective laparoscopic sleeve gastrectomy with one or more of the following risk factors for breakthrough visceral/autonomic symptoms:
- Female sex age <30 years
- Prior history of severe postoperative pain after abdominal surgery
- Prior history of significant postoperative nausea/vomiting
- History of opioid intolerance or significant opioid-related adverse effects
- Allergy/intolerance to multiple postoperative analgesics/antiemetics
- Concomitant hiatal hernia repair
- Surgeon's judgment of elevated visceral symptom risk based on prior institutional experience
Who cannot join
- Contraindication to local anesthetics or dexamethasone
- Chronic opioid dependence
- Severe psychiatric or cognitive impairment limiting symptom assessment
- Pregnancy
- Conversion to open surgery
- Inability or unwillingness to comply with the postoperative reporting protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Targeted Temporary In Situ Catheter Redosing of Autonomic Neural Blockade for Breakthrough Symptoms After Laparoscopic Sleeve Gastrectomy
Postoperative visceral pain and autonomic symptoms after laparoscopic sleeve gastrectomy may reappear earlier in selected high-risk patients despite standard intraoperative autonomic neural blockade (ANB). Temporary in situ catheter placement permits postoperative ANB redosing when breakthrough visceral symptoms occur.
This prospective single-arm observational study will evaluate the feasibility, safety, and clinical effectiveness of temporary ANB catheter placement and selective postoperative redosing in high-risk patients undergoing laparoscopic sleeve gastrectomy.
Read the detailed description
Autonomic neural blockade (ANB) selectively modulates visceral pain and autonomic symptoms after minimally invasive upper gastrointestinal surgery. Prior randomized trials have demonstrated reductions in pain, analgesic requirements, PONV, and anesthetic consumption following ANB during laparoscopic sleeve gastrectomy (LSG). However, breakthrough visceral symptoms may occur in selected patients after blockade wanes.
A prior feasibility study by our group demonstrated that temporary in situ catheter placement for postoperative ANB redosing after LSG is technically feasible and safe, establishing catheter selection, placement strategy, and anatomical targets.
This prospective pilot study evaluates the clinical utility of selective postoperative ANB redosing in predefined high-risk patients.
All participants will undergo standard intraoperative ANB, TAP block, and temporary catheter placement in one of three anatomically validated paragastric/celiac pathway locations. Scheduled acetaminophen will be administered postoperatively.
Prior to any redosing, the treating investigator will clinically assess whether symptoms are consistent with visceral/autonomic breakthrough rather than somatic/incisional pain. Pain characteristics suggesting visceral origin include diffuse, deep, poorly localized epigastric/substernal discomfort, associated nausea/vomiting, autonomic symptoms, or pain disproportionate to abdominal wall tenderness.
Patients meeting redosing criteria will receive catheter redosing with 15 mL of 0.5% bupivacaine plus 4 mg dexamethasone. The minimum interval between re-dosing will be eight hours.
Concomitant hiatal hernia repair will be recorded for all patients, given the potential influence of distal phrenic nerve blockade on postoperative symptom patterns.
- Being tested
- Bupivacaine 0.5% and Dexamethasone via Temporary Catheter
- Keywords
- Autonomic neural blockade, visceral pain, postoperative nausea and vomiting, re-dosing, temporal catheter
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Visceral Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.5% and Dexamethasone via Temporary CatheterOther
Autonomic neural blockade (ANB) re-dosing will be performed by administering bupivacaine 0.5% and dexamethasone through a temporary catheter placed in the paragastric area during laparoscopic sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Catheter Re-dosing for Breakthrough Symptoms After LSG | Experimental | Participants with breakthrough symptoms, defined as visceral pain of 4/10 or higher, postoperative nausea, or vomiting, will receive 15 mL of bupivacaine 0.5% plus dexamethasone 4 mg through the temporary catheter. Symptom response will be recorded 15 minutes after administration. Catheter re-dosing may be repeated if breakthrough visceral/autonomic symptoms recur, provided that at least 8 hours have elapsed since the prior dose and the participant remains under direct institutional supervision. The catheter will be removed 24 hours postoperatively or before hospital discharge, whichever occurs first. Receives: Other: Bupivacaine 0.5% and Dexamethasone via Temporary Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response to autonomic neural blockade(ANB) Redosing
Change in visceral pain score measured on a 10-point visual analog scale before and after autonomic neural blockade re-dosing. A clinically meaningful response is defined as a reduction of 2 or more points.
Measured: Up to 24 hours postoperatively
Resolution of Postoperative Nausea or Vomiting After ANB Re-dosing
Resolution of postoperative nausea or vomiting when present before autonomic neural blockade re-dosing, assessed as present or absent after treatment.
Measured: Up to 24 hours postoperatively
Proportion of Participants With Successful Temporary Catheter Placement and Function
Successful temporary catheter placement and function, assessed as a binary yes/no measure. Success is defined as intraoperative placement of the catheter in the intended paragastric location with catheter patency sufficient to allow postoperative administration of the study intervention if clinically indicated.
Measured: Intraoperative through 24 hours postoperatively
Secondary outcomes (6)
Incidence of Clinically Significant Breakthrough Visceral Symptoms Despite Standard Intraoperative ANB
Proportion of enrolled patients requiring at least one postoperative catheter re-dosing.
Measured: Up to 24 hours postoperatively
Number of Re-dosing Events Per Patient
Total number of postoperative autonomic neural blockade catheter re-dosing episodes administered to each participant during the postoperative catheter-use period.
Measured: Up to 24 hours postoperatively
Safety of Temporary ANB Catheter Technique
Incidence of catheter-related or ANB-related adverse events, including:
- Bleeding
- Infection
- Catheter dysfunction requiring premature removal or preventing intended redosing.
Measured: 8 postoperative days
Postoperative Pain Scores Compared with Historic Institutional Controls
Comparison of postoperative pain scores measured using the Visual Analog Scale for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Scores will be compared at 8, 24, and 48 hours after surgery with a prior institutional laparoscopic sleeve gastrectomy cohort managed under an identical perioperative protocol but without catheter placement or autonomic neural blockade re-dosing. In participants requiring re-dosing, pain scores obtained before rescue intervention will be used for comparison.
Measured: 8, 24, and 48 hours postoperatively
Postoperative Nausea and Vomiting Compared with Historic Institutional Controls
Comparison of postoperative nausea and vomiting events at 8, 24, and 48 hours after surgery with a prior matched institutional laparoscopic sleeve gastrectomy cohort managed under an identical perioperative protocol but without catheter placement or ANB redosing. In patients requiring redosing, the presence of nausea or vomiting documented prior to rescue intervention will be used for comparison.
Measured: 8, 24, and 48 hours postoperatively
Re-dosing Requirement by Concomitant Hiatal Hernia Repair Status
Exploratory comparison of the proportion of participants requiring at least one postoperative catheter re-dosing between participants undergoing laparoscopic sleeve gastrectomy with versus without concomitant hiatal hernia repair.
Measured: Up to 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain, Acute Post-OperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Simón Bolívar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Daes, MD, Principal investigator, clinica Iberoamerica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655908
- Sponsor's protocol ID
- CI0012026
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the study protocol, statistical analysis plan (SAP), informed consent form (ICF), and selected de-identified participant-level data upon reasonable academic request after publication of the study results.
Publications
Daes, J., Luque, E., Hanssen, A. (2025). Intraoperative Autonomic Blockade: Enhancing Anesthesia and ERAS Protocols in Laparoscopic Sleeve Gastrectomy. In: Gagner, M., Ramos, A.C., Palermo, M., Noel, P., Nocca, D. (eds) The Perfect Sleeve Gastrectomy. Springer, Cham. https://doi.org/10.1007/978-3-031-77690-8_104-1
Daes, J.; García-De La Rosa, D.; Eric M., P. Temporary in Situ Catheters to Extend Autonomic Neural Blockade After Laparoscopic Sleeve Gastrectomy: A Feasibility and Safety Study. Rev Colomb Cir 2026.
Daes J, Pantoja R, Luque E, Hanssen A, Rocha J, Pauli EM. Intraoperative autonomic neural blockade: comparison between different local anesthetics combinations: a randomized clinical trial. Surg Endosc. 2025 Apr;39(4):2523-2533. doi: 10.1007/s00464-025-11637-0. Epub 2025 Mar 3.
PubMed 40032662Daes J, Hanssen A, Luque E, Mercado J, De la Rosa DG, Pauli EM. Effect of intraoperative autonomic neural blockade on early postoperative outcomes after laparoscopic cholecystectomy: a double-blind randomized controlled trial. Surg Endosc. 2026 Apr;40(4):2894-2901. doi: 10.1007/s00464-025-12542-2. Epub 2026 Jan 13.
PubMed 41530355Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.
PubMed 38091501Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.
PubMed 36050617Daes J, Pauli E. Autonomic Neural Blockade in Minimally Invasive Surgery. JAMA Surg. 2024 Dec 1;159(12):1433-1434. doi: 10.1001/jamasurg.2024.2334.
PubMed 39382864